CHMP backs J&J TB compound, Piramal imaging agent
EMA's CHMP recommended conditional approval of an MAA from Johnson & Johnson (NYSE:JNJ) for Sirturo bedaquiline to treat pulmonary multi-drug resistant tuberculosis (MDR-TB) in adults. The recommendation covers use of bedaquiline as part of a combination therapy when alternative treatments cannot be used due to resistance or intolerance. Late last year, FDA granted accelerated approval to bedaquiline to treat adults with multi-drug resistant pulmonary TB as part of a combination therapy when other alternatives are not available (see BioCentury Extra, Jan. 2).
Last month, CHMP backed approval of two other compounds for MDR-TB -- Deltyba delamanid from Otsuka Pharmaceutical Co. Ltd. (Tokyo, Japan) and Para-aminosalicylic acid Lucane from Lucane Pharma S.A. (Paris, France) (see BioCentury Extra, Nov. 22). ...